ASPIRIN DELAYED RELEASE- aspirin tablet, delayed release 
Time-Cap Labs, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ASA D-R 81MG 349R

Active ingredient (in each tablet)


Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose


PAIN RELIEVER

Uses


Do not use


Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

IF pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

anhydrous lactose, black iron oxide, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD-C red 40 aluminum lake, FD-C yellow 6 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, triethyl citrate

ASPIRIN 81MG PEACH TABLETS 349R BULK LABEL

ASPIRIN  DELAYED RELEASE
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-349
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg  in 81 
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
Colororange (PEACH) Scoreno score
ShapeROUNDSize7mm
FlavorImprint Code L277
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-349-00100000 in 1 CARTON; Type 0: Not a Combination Product12/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/23/2010
Labeler - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time-Cap Labs, Inc037052099manufacture(49483-349)

Revised: 12/2018
Document Id: 7cff0ad4-677a-03f7-e053-2a91aa0af7ae
Set id: 70d8ba6c-8dfe-402a-817d-22544141d160
Version: 3
Effective Time: 20181214
 
Time-Cap Labs, Inc